Waco Dermatology

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) (a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. In addition, retain the following: (a)(6)(i) Immunohematology reports as specified in 21 CFR 606.160(d). (a)(6)(ii) Pathology test reports for at least 10 years after the date of reporting This STANDARD is not met as evidenced by: Based on review of patient test reports, slides, and interview the laboratory failed to retain Mohs test reports for at least 10 years from the report date for two of two reports from 2016. Findings follow. A. Review of 2 of 2 patient test reports older than 2 years, but less than 10 years, showed the test reports and maps for the random slides selected from 02/23/2016 and 10/04/2016 were unavailable for review. B. Interview with the Practice Manager on April 7, 2025 at 1530 hours in the office acknowledged they were cited for this last inspection, and at the time, if a patient had not been seen in the last seven years, the file was sent to offsite storage. The slides only had the first name of the patient and initial of first name with no date of birth making it virtually impossible for the staff to identify the patient to pull a report. Interview with the histotech on April 7, 2025 at 1600 hours in the office confirmed Mohs logs from 2016 and 2017 were not retained to reference and identify the patients. And, the maps from 2016 and 2017 could not be found. C. Review of the CMS Form 116 showed an estimated annual test volume of 255 stages per year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's reagent log, observation, interview, and pre- survey paperwork, the laboratory failed to retain the chemical name and concentration (if applicable), manufacturer, lot number, expiration date, received date, open date of the chemicals and stains used in the laboratory for the Hemotoxylin and Eosin (H&E) stain used in Mohs processing for two of two years reviewed. Findings follow. A. Review of the reagent log from 08/31/2021 - 08/31/2023 showed one chemical (RGA 95) logged in the last two years. B. During a tour of the laboratory on August 31, 2023 at 1200 surveyor observed no chemicals or stains available for use in the laboratory. C. Interview with the Clinic Manager on August 31, 2023 at 1030 hours in the office confirmed the findings. Further interview with the Clinic Manager on August 31, 2023 at 1205 hours in the office acknowledged chemicals were either expired or close to expiration and were thrown out prior to inspection. D. Review of the CMS Form 116 showed an estimated annual test volume of 240 stages. II. Based on review of Mohs testing logs, pre-survey paperwork, and interview, the laboratory failed to retain the Mohs testing logs for two of two years reviewed. Findings follow. A. Mohs testing logs from 08/31/2021 - 08/31/2023 were requested on August 31, 2023 at 1015 but not provided. B. Review of the CMS Form 116 showed an estimated annual test volume of 240 stages. C. Interview with the Clinic Manager on August 31, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 2023 at 1015 in the office acknowledged the histotech did not leave the testing logs in the laboratory and added there was a gap in testing from 07/20/2022 - 04/17/2023, and Mohs testing was performed once per month. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of patient test reports, slides, interview, and pre-survey paperwork, the laboratory failed to retain Mohs test records for at least 10 years from the report date for one of two reports older than two years reviewed. Findings follow. A. Random review of two Mohs cases from 09/25/2014 and 11/16/2014 showed one test report was unavailable for review. B. Interview with the Clinic Manager on August 31, 2023 at 1115 hours in the office acknowledged if a patient has not been seen in the last seven years, the file is sent to offsite storage. C. Review of the CMS Form 116 showed an estimated annual test volume of 240 stages. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure, accuracy assessments, and interview, the laboratory failed to establish written policies and procedures for Mohs peer review to include clear margins on final stage, accurate maps and slides, and slide quality for documentation from the peer in Mohs testing to show agreement for two of two events reviewed. A. Review of the laboratory's policies and procedures showed they did not have a quality assurance policy. B. Review of the accuracy assessments by peer review showed no documentation from the peer on the agreement of the Mohs testing performed for the 05/16/2023 and 04/18/2023 events, or whether there were clear margins on the final stage, accurate maps and slides, and slide quality. C. Interview with the Clinic Manager on August 31, 2023 at 1000 hours in the office acknowledged the peer reviews were done by conference call and there was no documentation from the peer showing agreement for the Mohs testing, and the documentation for accurate diagnosis was performed by the Clinic Manager. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Review of the CMS form 209 Laboratory Personnel Report, policies and procedures, personnel files and interview of facility personnel found that the laboratory did not have a procedure for assessing the competency of all testing personnel and supervisors involved in histopathology testing. The findings included: 1. Review of the CMS 209 Laboratory Personnel Report found the Laboratory Listed 2 Testing Personnel , one general supervisor, 1 technical supervisor performing high complexity procedures. 2. Review of policies and procedures found no written policy to assess the competency of all testing personnel, consultants and supervisors. 3 . competency assessment records for testing person 2 (hired January 2019) listed on the CMS report 209 were requested on February 18, 2020 at 3:32 PM. 4. Interview of the histotechnician conducted on February 18, 2020 at 3:35 PM confirmed that the laboratory did not have a written policy to assess the competency of the consultants, supervisors and testing personnel. She went on to say that testing person 2 was hired in January and no semiannual competency assessments had been performed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, quality assurance records from 2016 through 2018 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for MOHS testing. Findings included: 1. A review of the laboratory's policy and procedure manual found no written policy for performing twice annual accuracy assessment of MOHS testing. 2. Records of twice annual accuracy assessment for 2018 and 2019 were requested but not provided. 3. Interview of the histotechnician conducted on February 18, 2020 at 2: 46 PM confirmed that no records were available for review that would ensure that the laboratory verified the accuracy of their work at least twice each year in 2018 and 2019. She stated they did it, but do not have record of it. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records, MOHS procedures and interview of facility personnel, the laboratory failed to document the negative and positive reactivity of quality control slides for Hematoxylin and Eosin (H and E) staining on each day of patient testing between January 2018 and February 2020. The findings included: 1. Based on review of H and E stain quality control logs between January 2018 and March 2019 the laboratory documented acceptability of stain reactivity using a "+" in the column titled acceptable for each day of the month and the initials of the individual responsible for reading slides. There was no key to define the + response. 2. Review of the procedure titled MOH's section procedure found: " once sllide is stained and coverslipped check quality under Mohs scope and deliver to testing personnel for review ". There was no legend of symbols used for quality control responses in the procedure. 3. Interview of the histotechnician conducted on February 18, 2020 at 2:29 PM confirmed that the laboratory does not document intended reactivity of negative and positive control tissues each day of patient testing for H and E staining. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory policies, and staff interview, it was revealed the laboratory director failed to ensure a quality assessment program was established and maintained to detect failures in quality of performance for histopathology testing. The finding were as follows: 1. Review of laboratory policies and procedures found no quality assurance plan specific to the laboratory services provided. 2. Interview of the -- 2 of 3 -- histotechnician confirmed that the laboratory did not have a quality assurance plan specific to laboratory services. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: The laboratory director failed to ensure there was a procedure in place to assess the competency all testing personnel involved in preanalytic, analytic and postanalytic testing of histopathology specimens. (See D5209) D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency at least semiannually during the first year the individual tests patient specimens for one of two testing personnel performing histopathology procedures. The findings included: 1. Review of personnel files found testing person two (hired January 2019) had no record of semiannual competency evaluation during the first year of testing. 2. Interview of the histotechnician conducted on February 18, 2020 at 3:32 PM confirmed that competency assessments had not been performed and documented at least semiannually for the first year of testing for testing person 1. -- 3 of 3 --